FDA Registration
Active
🇨🇦 Canada
59145 Pak-Its Gauze Iodoform Packing Strips with Strip Delivery System Size 1/4" x 5 yd
Reg #: 9680091
·
FEI: 3002806830
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DERMA SCIENCES CANADA, INC (dba DERMA SCIENCES, INC.)
- Registration Number
- 9680091
- FEI Number
- 3002806830
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 104 SHORTING RD.
- City
- TORONTO Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K921291
Owner / Operator
- Firm Name
- GENTELL
- Operator Number
- 10026501
- Address
- 180 Rittenhouse Circle,
- City
- Bristol
- State
- PA
- Postal Code
- 19007
- Country
- US
- Correspondent
- Michael Alford
US Agent
- Business Name
- GENTELL
- Contact Name
- Michael Alford
- Address
- 1000 Floral Vale Blvd Ste 400
- City
- Morrisville
- State
- PA
- ZIP
- 19067
- Country
- US
- [email protected]
- Phone
- 800 8409041
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Anoscope And Accessories | FER | Class 2 | Gastroenterology, Urology | No | 2022-10-28 |
Proprietary Names
59145 Pak-Its Gauze Iodoform Packing Strips with Strip Delivery System Size 1/4" x 5 yd
59445 Pak-Its Gauze Iodoform Packing Strips with Strip Delivery System Size 2" x 5 yd
59245 Pak-Its Gauze Iodoform Packing Strips with Strip Delivery System Size 1/2" x 5 yd
59345 Pak-Its Gauze Iodoform Packing Strips with Strip Delivery System Size 1" x 5 yd
59146 Pak-Its Gauze Iodoform Packing Strips Size 1/4" x 5 yd
59346 Pak-Its Gauze Iodoform Packing Strips Size 1" x 5 yd
59246 Pak-Its Gauze IodoformPacking Strips Size 1/2" x 5 yd
Establishment Types
Manufacture Medical Device